Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Extracorporeal Blood Purification Using Efferon LPS Hemoadsorption in Patients With Thermal Burns: Pilot Study
The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181.
Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Burn injury is not only a local tissue injury at the site of the damaging agent, but also triggers a complex systemic response to trauma. Severe burn injury induces a systemic inflammatory response associated with generalized microcirculatory disturbances in organs and tissues, cellular dystrophy and destruction, and the development of multiple organ dysfunction and failure. Burn trauma causes massive release of damage-associated molecular patterns (DAMPs) and pro-inflammatory cytokines, leading to systemic inflammatory response syndrome (SIRS), which may result in multiple organ failure and death. Mortality associated with multiple organ failure in burn patients reaches 81-87% among patients who develop this condition, and multiple organ failure remains the leading cause of death in burn patients. Among patients with a Sequential Organ Failure Assessment (SOFA) score ≥4 within the first 24 hours after injury, mortality reaches 81%.
The Efferon LPS hemoadsorption device was developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential in the treatment of burn injury, a condition characterized by a complex inflammatory response.
The goal of this study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon LPS device to reduce the severity of clinical manifestations and to prevent progression of multiple organ dysfunction, or mitigate it if already developed, in patients with burn disease and an RFI score ≥71 and ≤181.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alexandr Shelehov-Kravchenko, PhD, MD
- Numéro de téléphone: +79636564765
- E-mail: ais@efferon.ru
Lieux d'étude
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Moscow, Russie, 129090
- N.V. Sklifosovsky Research Institute for Emergency Medicine
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Contact:
- Vladimir Kulabukhov, PhD, MD
- Numéro de téléphone: +79255068081
- E-mail: v.kulabukhov@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Thermal burns (flame, scald, or contact burns), including cases combined with inhalation injury
- Revised Frank Index (RFI) score ≥71 and ≤181
- Indication for extracorporeal therapy within the first 10 days after injury
- The patient's condition allows Efferon LPS therapy to be performed for at least 6 hours
Exclusion Criteria:
- Isolated thermal-inhalation injury
- Chemical, electrical, or solar burns of the skin
- Combined skin burns with frostbite and/or general hypothermia
- Combined trauma (electrical injury; traumatic brain injury other than concussion or mild cerebral contusion; skull, spinal, thoracic, pelvic, or femoral fractures) or acute pre-existing pathology prior to hospital admission (acute myocardial infarction, stroke, community-acquired pneumonia, or acute surgical conditions) that may influence the course and outcome of burn disease
- Cardiopulmonary resuscitation at the pre-hospital stage
- End-stage renal disease
- Acute pulmonary embolism confirmed by imaging
- Emergency surgical treatment
- Any other condition which, in the investigator's opinion, precludes inclusion of the patient in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Baseline therapy
Patients receiving standard treatment for the treatment of thermal burns without the use of hemoadsorption methods, but who are prescribed continuous renal replacement therapy (CRRT) for renal and non-renal indications.
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Expérimental: Baseline therapy + Efferon LPS
Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT).
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Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity.hemoadsorption
procedures, each lasting 6-12 hours, with an interval of at least 24 hours between hemoadsorption sessions (from the start of the first procedure).
The procedures are performed in combination with continuous renal replacement therapy (CRRT).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Need for vasopressor support
Délai: 1-28 days
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Need for vasopressors according to the Vasoactive inotropic score (VIS 2020) heart rate scale.
VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.
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1-28 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Horowitz oxygenation index
Délai: 1-28 days
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Value of oxygenation index (Pa02 / Fi02 (Pa).
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1-28 days
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Renal replacement therapy (RRT) free days
Délai: 1-28 days
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RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. RRT-free days = 0 if the subject requires RRT for more than 28 days. |
1-28 days
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28 and 60 days mortality
Délai: 1-60 days
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Mortality rate
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1-60 days
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Length of stay in the intensive care unit
Délai: 1-60 days
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Time (number of days) from study enrollment to transfer from the intensive care unit within 60 days
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1-60 days
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Duration of hospitalization
Délai: 1-60 days
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Time (number of days) from study enrollment to discharge from the hospital
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1-60 days
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Frequency of septic complications
Délai: 1-28 days
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Percentage of patients with septic complications
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1-28 days
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Frequency of surgical interventions
Délai: 1-28 days
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Percentage of patients requiring surgery
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1-28 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Vladimir Kulabukhov, PhD, MD, N.V. Sklifosovsky Research Institute for Emergency Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- efferon-lps-2026-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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